Agency classClass IOur severity:Severe FDA (Devices)·Z-0866-2015·Announced 2014-12-31

Halyard KimVent Endotracheal Tubes Recalled for Cuff Line Detachment

Halyard Health is recalling KimVent Microcuff Endotracheal Tubes because the cuff inflation line may detach from the tube during use.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which is defined as a situation where use of or exposure to a violative product may cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls must be scored at least 4.

Plain-English summary

Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes, 7.5 mm, distributed by Kimberly Clark Global Sales, LLC. The product is used for airway management by oral intubation of the trachea and for the removal of secretions that accumulate in the subglottic space.

The recall is being issued because the cuff inflation line may detach from the endotracheal tube during use. This defect could compromise the device's intended function for airway management and secretion removal.

The recall involves 430 cases, with 10 tubes per case. The affected products were distributed nationwide in the United States and in several international locations, including Australia, Canada, Europe, Hong Kong, New Zealand, and the United Arab Emirates. Specific lot numbers are listed in the structured product information. Healthcare providers and facilities should stop using the affected lots and contact the recalling firm for instructions on return or replacement.

The recalled product

Product: KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Manufacturer: Halyard Health
Category: Medical Device — Endotracheal Tubes
Hazard: device-failure
component-detachment

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Product Code: 13221
Lot numbers: AA3213
AA3213V01
AA3231
AA3231V01
AA3249
AA3249V02
AA3253
AA3253V01
AA3274
AA3274V03
AA4062
AA4062V02
AA4062V06
AA4097
AA4097V01
AA4097V03
AA4125V01
AA4134V02
AA4140

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Halyard Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Halyard Health

See all →

Moderate
Halyard Health Recalls Sterling Nitrile Sterile Exam Gloves Due to Defects
FDA (Devices) · 2016-12-21
High
Halyard Health Recalls KimVent Closed Suction Systems Due to Air Leak Defect
FDA (Devices) · 2015-03-11
High
Halyard Health Recalls KimVent Closed Suction Systems Due to Defects
FDA (Devices) · 2015-03-11
High
Halyard Health Recalls KimVent Wet Pak Closed Suction Systems
FDA (Devices) · 2015-03-11
Severe
Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk
FDA (Devices) · 2014-12-31

Same hazard · device failure